New Safety Concerns On ESAs Prompt FDA To Consult ODAC
By Paul Goldberg
The Cancer Letter, volume 34, no 1
On Dec. 4, 2007 Amgen informed FDA of the results of
a study by the NCI Gynecologic Oncology Group of
chemotherapy and radiation for advanced cervical
cancer. The patients were administered either
Procrit, a drug licensed to Johnson & Johnson, to
maintain hemoglobin levels above 12 g/dL, or
blood transfusions as needed. After three years,
66 percent of the patients who did not take
Procrit were alive and free of cancer growth,
compared to 58 percent who had received the drug.
The study closed prematurely with less than 25
percent of planned enrollment, because of concerns about thromboembolic events.
Both studies sought to increase hemoglobin
above12 g/dL, the upper limit noted on the ESA label.
12/12/06 email from advocate:
I just wanted to tell people that you can change things in the medical
community. The "Silent Killer" nomenclature associated with ovarian cancer
has been slayed. It's taken a long time and a lot of effort. Cindy
Melancon, one of our ocers worked with Barbara Goff, a gyn/onc from Seattle
to start the research that has led to this.
Unfortunately Cindy died from
ovarian cancer in June of 2002 but her legacy lives on in the continuing
support her newsletter, Conversations, gives to women diagnosed with oc.
However, the survey that Cindy sent out in her newsletter (where 200 more
copies were returned than were sent out) on symptoms women experienced
before diagnosis, led to the research that has now resulted in a CME on
Ovarian Cancer Symptoms.
I can't begin to tell you all how much this means
to our community and wanted to share this accomplishment so you'll know we
can make a difference.
Diane (email 12/21/06)
From MEDSCAPE: Early detection of ovarian cancer is possible through an evaluation of specific symptoms of recent onset and significant frequency, according to the results of a case-control study reported in the December 11 Early View issue of Cancer.
When your symptoms are persistent and other explanations don't work, make sure you and your doctor know the following:
Ovarian Cancer Facts:
Occurs in 1 out of 55 women, at any age
Most women are diagnosed when the chance of survival for 5 years is about 20%. Early detection improves survival rate Ann's NOTE: A blood test LPA is currently being tested that may truly be able to detect very early (Stage 1) ovarian cancer. It is in clinical trial now. And remember, some women survive in every group.
Symptoms are subtle, persistent and usually increase over time:
bloating, a feeling of fullness, gas
frequent or urgent urination
nausea, indigestion, constipation, diarrhea,
menstrual disorders, pain during intercourse
TAKE ACTION If any symptoms last more than 2-3 weeks .Ask for a comgination pelvic/rectal exam, a CA 125 blood test and a transvaginal sonogram.
UPDATE: 6/04 (Source: MEDSCAPE.com - part of physician continuing education)
Of 1,709 women who visited two primary care clinics and completed an anonymous survey of symptoms experienced for the past year (July 2001 to January 2002), 128 women had ovarian masses.
In the overall clinic population, 72% reported recurring symptoms with a median number of two symptoms; 45% had back pain, 34% had fatigue, 27% had bloating, 24% had constipation, 22% had abdominal pain, and 16% had urinary symptoms.
Compared with controls, ovarian cancer cases had significantly increased odds ratios for increased abdominal size (7.4), bloating (3.6), urinary urgency (2.5), and pelvic pain (2.2). Compared with women with benign masses or with controls, women with ovarian cancer had significantly more symptoms of higher severity and more recent onset, and they typically experienced symptoms 20 to 30 times per month. The symptom pattern of bloating, increased abdominal size, and urinary symptoms was reported by 43% of women with ovarian cancer but by only 8% of the overall primary care clinic population.
"While our current study did find that women who present to primary care clinics frequently have vague symptoms that can be associated with ovarian cancer, the important difference is that these symptoms are less severe and less frequent when compared with women with ovarian cancer," the authors write. "Women with ovarian cancer typically have symptoms of recent onset and have multiple symptoms that coexist. This study adds further evidence that ovarian cancer is not a silent disease."
The Ovarian Cancer Research Fund, Inc., supported this study.
JAMA. 2004;291:2705-2712, 2755-2756
A Pap smear is NOT an effective detection method for ovarian, it is for cervical. See below for an effective test-HPV DNA for cervical cancer.
Uterine cancer (endometrial cancer)' most prominent symptom is unexpected/irregular vaginal bleeding.
From: The Ovarian Cancer National Alliance, 1627 K Street NW, 12th Fl. Washington, D.C. 20006 (202) 331-1332
DO NOT USE TALC (Talcum) POWDER GENITALLY. This is a known risk factor. Studies have identified the use of talc as contributing factor to ovarian cancer. You can use cornstarch as a substitute.
Take a look at MAMM Magazine which features articles about ovarian, cervical, endometrial, breast cancers and more. www.mamm.com
(special sections on Lesbian Health Issues and Women with Different Abilities are found on the Breast Cancer Issues page)
12/05 Using Intrperitoneal Cisplatin and Paclitaxel was life extending but the unwanted ('side') effects are very strong. There are many bits of information on this site on how to reduce effects from chemotherapy. Please think about combining/integrating them. Speak to your physican, download articles from this site to help open a dialogue.